Generic Name and Formulations:
Cabazitaxel 60mg/1.5mL; soln for IV infusion after dilution; contains polysorbate 80, diluent contains ethanol.
Indications for JEVTANA:
In combination with prednisone for the treatment of metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.
Premedicate with IV antihistamine, corticosteroid, and H2 blocker 30 mins before each dose (see full labeling) and with antiemetic (IV or oral as needed). Infuse over 1hr. 20mg/m2 every 3 weeks, with oral prednisone 10mg/day during treatment; 25mg/m2 may be used in select patients. Prolonged grade ≥3 neutropenia (>1 week), febrile neutropenia, grade ≥3 diarrhea, grade 2 peripheral neuropathy: delay treatment and/or reduce by one dose level (see full labeling). Discontinue if grade ≥3 peripheral neuropathy. Hepatic impairment: (mild): 20mg/m2; (moderate): 15mg/m2. If concomitant strong CYP3A inhibitor necessary, consider a 25% cabazitaxel dose reduction.
Neutrophil count ≤1,500cells/mm3. Allergy to polysorbate 80. Severe hepatic impairment (total bilirubin >3xULN). Pregnancy.
Increased risk of neutropenia complications; consider G-CSF prophylaxis (recommended in high risk patients). Monitor CBC weekly in 1st cycle and before each subsequent cycle. Patients with hemoglobin <10g/dL; monitor closely. Monitor for hypersensitivity reactions esp. during 1st and 2nd infusions; discontinue if occur. Increased risk of GI disorders in patients with neutropenia, age, or history of pelvic radiotherapy, adhesions, ulceration, and GI bleeding. Evaluate and treat if serious GI toxicity occurs; treatment delay or discontinuation may be needed. Underlying lung disease. Monitor closely for respiratory disorders; interrupt if new or worsening pulmonary symptoms develop. Monitor for cystitis in patients who previously received pelvic radiation; interrupt or discontinue if severe hemorrhagic cystitis occurs. Hepatic impairment (monitor). ESRD (CrCl <15mL/min). Elderly (increased susceptibility to adverse reactions); monitor closely. Males with female partners of reproductive potential must use effective contraception during and for 3 months after last dose. Nursing mothers.
Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole); avoid. May be antagonized by rifampin. Increased GI toxicity with concomitant steroids, NSAIDs, antiplatelets, anticoagulants.
Bone marrow suppression (esp. neutropenia, anemia, leukopenia, thrombocytopenia), diarrhea (may be fatal), fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, alopecia; febrile neutropenia, renal failure, hypersensitivity reactions.
Kit (single-use vial + diluent)—1